Naturalistic Substitution of Concerta in Adult Subject With ADHD Receiving Immediate Release Methylphenidate
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|ClinicalTrials.gov Identifier: NCT00302406|
Recruitment Status : Completed
First Posted : March 14, 2006
Last Update Posted : July 12, 2011
This is a single-blind study looking at the efficacy and satisfaction of Concerta substitution in adult subjects with ADHD receiving immediate release methylphenidate. Subjects will be administered a maximum dose of 1.3mg/kg/day of either methylphenidate or Concerta. The specific hypotheses of this study are:
Hypothesis 1: ADHD symptomatology in adults with DSM-IV, ADHD will continue to be controlled in patients switched from MPH IR TID to Concerta.
Hypothesis 2: Patient satisfaction will not decrease in patients switched from MPH IR TID to Concerta (ie., all patients will be equally or more satisfied on Concerta as compared with MPH IR TID.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: methylphenidate hydrochloride Drug: OROS methylphenidate hydrochloride (CONCERTA)||Phase 4|
Concerta was specifically developed to replace three times a day immediate release (IR) methylphenidate (MPH). The clinical advantages offered by this novel compound go beyond ease of administration. By avoiding the peaks and valleys of serum levels associated with IR MPH, treatment with Concerta minimizes adverse effects at peaks and break through symptoms at valleys securing clinical coverage throughout the day, minimizing the risks of adverse effects from serum fluctuations that can occur with multiple dosing of the IR formulation of MPH. This unique pharmacokinetic and pharmacodynamic profile of Concerta is potentially particularly advantageous in the treatment of adults with ADHD because a) adults with ADHD tend to be forgetful; b) forgetfulness makes the self administration of treatment three times a day difficult; c) forgetfulness can lead to poor compliance and drop off of effects over time with its attendant detrimental effect on clinical control and quality of life. Subjects will be randomized by the pharmacy to CONCERTA or to continue MPH IR TID in a ratio of 4:1.
This study includes: 1) a six-week design to document the response rate 2) assessment of the impact of either MPH IR or Concerta on functional capacities 3) careful assessment of safety and tolerability
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Naturalistic Substitution of Concerta in Adult Subject With ADHD Receiving Immediate Release Methylphenidate|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
- Primary Outcomes: maintenance of symptom control when switched from TID IR MPH to Concerta administered once a day in the AM and to assess if this differs from 100%, the value one would expect if Concerta maintained efficacy in all subjects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302406
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Thomas Spencer, MD||Massachusetts General Hospital|